The FDA’s May 2021 draft guidance for post-approval studies for PMA devices did not present any regulatory novelties, but did propose tighter timelines for filing, reviewing and fulfilling post-approval study (PAS) protocols. However, a review of the agency’s PAS database suggests that both the agency and industry might have a difficult time complying with the proposed new standards for turnaround times for these studies.

Intervenn Biosciences raised $201 million in a series C financing led by new investors Softbank Group, Heritage Provider Network, Irving Investors and Highside Capital Management. The proceeds are earmarked to speed development and commercialization of Dawn, a liquid biopsy assay for immune checkpoint inhibitor prediction, and to expand the network of partnerships on the company’s artificial intelligence (AI)-driven glycoproteomics platform.

Citing a unanimous U.S. Supreme Court ruling in April that denied the Federal Trade Commission’s (FTC) ability to seek restitution or disgorgement, the FTC, on July 30, withdrew its remaining count against Abbvie Inc. involving sham litigation intended to delay generic competition to its blockbuster testosterone replacement drug, Androgel.

South Korea’s Ministry of Food and Drug Safety (MFDS) has given innovative medical device designation for Te Bios Co. Ltd.’s artificial cornea, C-Clear, bringing it one step closer to becoming the first artificial cornea to be approved in the country.

PARIS – At some point, scientists reported, it may be possible to quarantine viruses rather than humans. For the last two years, European research consortium Virofight has been working on a form of nanotechnology intended to neutralize viruses such as SARS-CoV-2, HIV, influenza and hepatitis viruses.